The LANCET Trial: A Trial of Long-acting Insulin Injection to Reduce C-reactive Protein in Patients With Type 2 Diabetes

• Status: Terminated
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study, which is being conducted at 100 centers throughout the United States, is to determine whether Lantus, a long-acting insulin injection, either alone or in combination with metformin, is effective in reducing C-reactive protein (CRP) in adults with type 2 diabetes. CRP is a marker of chronic low-level inflammation, a new risk factor for diabetes, heart attack, stroke, and other cardiovascular events.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc; Metformin

Criteria

Inclusion Criteria:

• Men and women aged 18 to 79

• Type 2 diabetes, treated only by diet or oral drugs other than metformin

• HbA1c greater than or equal to 7% and less than or equal to 10%

• C-reactive protein greater than or equal to 2 mg/L

Exclusion Criteria:

• Baseline use of metformin or insulin

• Type 1 diabetes, history of ketoacidosis or positive anti-GAD antibody

• History of congestive heart failure requiring drug therapy

• Active liver disease

• Kidney impairment

• Recent initiation or change in dose of statins, fibric acid derivatives, angiotensin receptor blockers, nonsteroidal anti-inflammatory agents, or corticosteroids